MAUDE Adverse Event Report: COLLAGEN MATRIX, INC. DURAMATRIX SUTURABLE; COLLAGEN DURA MEMBRANE

Model Number	DMS22
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cerebrospinal Fluid Leakage (1772)
Date of Event	06/05/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Limited information provided.A patient diagnosed with chiari malformation had posterior fossa procedure performed on (b)(6) 2023.Duramatrix suturable was used.Further information surrounding the initial procedure was not specified.The patient presented with a csf leak post-op, and had to be brought back for "at least a shunt/drain" to fix the csf leak.Customer stated the patient was brought back for two post-op procedures: once on (b)(6) 2023 and another time on (b)(6) 2023.Per customer, patient was "brought back for a shunt on (b)(6) and also had a prior shunt after her surgery on (b)(6) 2023." adherus was also utilized for this patient, but it was not specified at what surgery (initial or one of the post-ops) the adherus was used.No issues or adverse events reported after revision surgery.No further information on patient status or patient outcome was provided.
Additional Manufacturer Narrative
Additional quality control testing showed the product met acceptance criteria.

• Brand Name: DURAMATRIX SUTURABLE
• Common Device Name: COLLAGEN DURA MEMBRANE
• Manufacturer (Section D): COLLAGEN MATRIX, INC.; 15 thornton road; oakland NJ 07436
• Manufacturer (Section G): COLLAGEN MATRIX, INC.; 15 thornton road; oakland NJ 07436
• Manufacturer Contact: peggy hansen ; 15 thornton road; oakland, NJ 07436
• MDR Report Key: 18279361
• Report Number: 2249852-2023-00027
• Device Sequence Number: 5909695
• Product Code: GXQ
• UDI-Device Identifier: 00813954020402
• UDI-Public: (01)00813954020402(17)241231(10)2206291121
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K141608
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 12/31/2024
• Device Model Number: DMS22
• Device Catalogue Number: DMS22
• Device Lot Number: 2206291121
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2023
• Initial Report FDA Received Date: 12/06/2023
• Date Device Manufactured: 06/30/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 47 YR
• Patient Sex: Female